Improving HIV Outcomes Among African American Transgender Women

Summary

The investigators will conduct a randomized controlled trial to test the efficacy of the mobile HIV behavioral intervention for African American transgender women (Shine). Participants will be 215 trans women recruited by staff of the Trans Women of Color Collective via community events and social media. Participants must : 1) identify as a Black transgender woman using the 2-step method (Step 1: assigned male birth sex, Step 2: current gender identity is female); 2) be aged 18 or older; 3) report risk of HIV transmission in past 3 months (i.e., CAS with a serodiscordant or risky partner AND either \<90% ART adherence or \<5 daily doses of PrEP per week); 4) own a smartphone; and 5) be able to read and speak English. Eligible participants who subsequently provide informed consent will complete two confidential phone-based research surveys at different time points (baseline and 6 months post-baseline) and will be randomly assigned to one of two conditions (Shine or mobile HIV education for transgender women).

Participants randomly assigned to the experimental condition will be instructed to text the word "Join" to the Shine study phone number. The intervention will take approximately 1-2 hours, with content delivered over several weeks. Participants randomly assigned to the control condition will be texted a link to a set of videos on healthy HIV-related behaviors for transgender women. These videos cover a variety of topics, including recommended testing frequencies, PrEP, and ART.

After randomization, participants will complete the baseline research survey. This survey will assess the primary outcome of composite HIV transmission risk along with several secondary outcomes (individual behavioral components of the composite score; HIV medical care utilization and adherence; HIV testing; PrEP knowledge, interest, and uptake; gender affirmation; well-being; social support; sexual communication). Six months after the baseline research survey, all participants will complete a follow-up research survey assessing the same outcome measures in the baseline research survey.

Binomial logistic regression will be the main analytic technique for the primary measure (composite risk for HIV transmission). For the secondary continuous measures, hierarchical linear modeling (HLM) will be used. All models will control for any demographic covariate (e.g., age) that varies at the .2 significance level due to randomization failure at baseline.

Conditions

• HIV

Interventions

BEHAVIORAL

Shine

This tailored, multifaceted mobile intervention aims to improve HIV-related outcomes and increase gender affirmation among African American transgender women. Potential users will opt-in by texting from their own mobile phone and, once registered, will be enrolled into a program that will be theory-based, targeted, tailored, and personalized. Users will receive three main types of texts: informational, motivational, and skill-building. Finally, the program will include three web-based video components: scripted vignettes, unscripted peer narratives, and educational instruction. By developing an intervention using a technology that is part of the everyday lives of most African Americans, the aim is to reduce HIV disparities. The proposed intervention can be used by clinics and community-based organizations that serve transgender women.

BEHAVIORAL

Control

A playlist of CDC-developed videos designed to provide information on HIV for transgender women

Sponsors & Collaborators

• ISA Associates, Inc.

  lead OTHER

Principal Investigators

• Samantha Leaf, Ph.D. · ISA Associates

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-16

Primary Completion

2023-01-20

Completion

2023-01-30

Countries

• United States

Study Locations